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Keep this study
Lead
Novan, Inc.
With
WCCT Global
This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day 21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period
Age
9–16
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Otherwise healthy male and female adolescent subjects with moderate to severe acne vulgaris on a 5 point IGA scale
At least 20 total inflammatory lesions (papules and pustules), and at least 20 total non-inflammatory lesions (open and closed comedones) on the face, chest, back, and shoulders
Age 9-16 years, 11 months inclusive
Subjects with methemoglobin level less than 3% at Screening and Baseline by pulse co-oximeter
You may not be if
Subjects with any other acne-like dermatological conditions such as severe, recalcitrant nodulocystic acne, acne conglobata, acne fulminans, acne secondary to medications or other medical conditions, perioral dermatitis, clinically significant rosacea, or gram-negative folliculitis;
Any subject with skin disorders of an acute or chronic nature including psoriasis, eczema, tinea versicolor, etc.
Subjects who reside in a dwelling that relies on well water for a primary drinking source
Subjects with facial hair (beards, mustaches, etc.), tattoos or other facial markings that would interfere with assessments and study drug application
Transgender subjects receiving hormone supplement (male to female or female to male)
Subjects with a previous history of methemoglobinemia or taking medications known to be associated with methemoglobinemia
Subjects with a known history of HIV, hepatitis, or other blood-borne pathogens
Females who are pregnant, planning a pregnancy or breastfeeding
Subjects previously treated with NVN1000 Gel / SB204
Clareo Health | Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
